Alkaline Picrate, Colorimetry, Creatinine
FDA product code CGX · Class II (moderate risk) · 21 CFR 862.1225 · Clinical Chemistry
159510(k) clearances
0PMA approvals
14recalls
Manufacturers
- Em Diagnostic Systems, Inc. 10
- Abbott Laboratories 8
- Harleco 8
- Olympus Corp. 6
- Beckman Coulter Inc. 4
- Siemens Healthcare Diagnostics, Inc. 4
- Synermed, Inc. 3
- Sigma Diagnostics, Inc. 3
- Amresco, Inc. 3
- American Research Products Co. 3
- Roche Diagnostic Systems, Inc. 3
- Hi Chem, Inc. 3
- Volu Sol Medical Industries 3
- Nobel Scientific Industries, Inc. 2
- Gilford Diagnostics 2
- Eastman Kodak Company 2
- Fisher Scientific Co., LLC 2
- Data Medical Associates, Inc. 2
- Beckman Instruments, Inc. 2
- American Monitor Corp. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252206 | Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track | Nova Biomedical Corporation | 01/09/2026SE |
| K251058 | Tru Kidney Health Test Panel; Tru AnalyzerCGX · Traditional | Truvian Health | 11/26/2025SE |
| K242685 | Atellica® CH Creatinine_3 (Crea3)CGX · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/04/2024SE |
| K221813 | Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track | Nova Biomedical Corporation | 11/19/2024SE |
| K210452 | Creatinine2CGX · Traditional | Abbott Ireland Diagnostics Division | 03/22/2022SE |
| K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)CGX · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/15/2016SE |
| K132638 | Dimension Creatinine (CRE2) Flex Reagent CartridgeCGX · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/27/2014SE |
| K133728 | Dimension Vista Creatinine (CRE2) Flex Reagent CartridgeCGX · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/24/2014SE |
| K123586 | Easyra Creatinine ReagentCGX · Special | Medica Corporation | 05/15/2013SE |
| K110530 | Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…CGX · Abbreviated | Horiba Abx SAS | 04/30/2012SE |
| K083809 | CreatinineCGX · Special | Abbott Laboratories | 04/07/2009SE |
| K072115 | Abx Pentra Creatinine 120 CP, Total Protein 100 CP, Multical, N and P Controls, and…CGX · Traditional | Horiba Abx | 11/30/2007SE |
| K071283 | Synchron Systems Creatinine ReagentCGX · Special | Beckman Coulter, Inc. | 06/01/2007SE |
| K071280 | Synchron CX Delta Clinical Systems, Creatinine Test SystemsCGX · Special | Beckman Coulter, Inc. | 06/01/2007SE |
| K071277 | Synchron LX20 Clinical Systems, Creatinine Test SystemsCGX · Special | Beckman Coulter, Inc. | 06/01/2007SE |
| K061193 | CreatinineCGX · Traditional | Abbott Laboratories, Inc. | 06/23/2006SE |
| K060935 | Synchron Systems Creatinine (Crea) ReagentCGX · Special | Beckman Coulter, Inc. | 04/28/2006SE |
| K050652 | Spotchem II Creatinine, Amylase & Alp TestsCGX · Traditional | Arkray, Inc. | 04/06/2005SE |
| K040976 | Genchem Creatinine ReagentCGX · Traditional | Genchem, Inc. | 12/27/2004SE |
| K033058 | Creatinine Reagent Kit for Beckman Synchron CX & CX Delta SystemsCGX · Traditional | Diamond Diagnostics, Inc. | 01/30/2004SE |
| K023407 | Atac Pak Creatinine Reagent and Atac CalibratorCGX · Traditional | Elan Diagnostics | 02/14/2003SE |
| K002156 | Appraise Urine Microalbumin Collection KitCGX · Traditional | Osborn Group, Inc. | 12/19/2000SE |
| K003247 | CreatinineCGX · Traditional | Jas Diagnostics, Inc. | 12/14/2000SE |
| K001769 | Vitros Chemistry Products Crea DT Slides; Vitros Chemistry Products DT Calibrator KitCGX · Special | Ortho-Clinical Diagnostics | 06/21/2000SE |
| K000055 | Creatinine-S Assay, Model 221-30, 221-50, 221-17CGX · Traditional | Diagnostic Chemicals , Ltd. | 02/18/2000SE |
| K991109 | Creatinine Reagent, Product No CR105-01, Creatinine Reagent, Product No CR105-02CGX · Traditional | A.P. Total Care, Inc. | 05/25/1999SE |
| K983937 | Dual Vial Creatinine ReagentCGX · Traditional | Intersect Systems, Inc. | 01/06/1999SE |
| K981799 | CreaCGX · Traditional | Abbott Laboratories | 07/22/1998SE |
| K981240 | Creatinine (Crea)CGX · Traditional | Abbott Laboratories | 05/29/1998SE |
| K973993 | Randox CreatinineCGX · Traditional | Randox Laboratories, Ltd. | 03/06/1998SE |
| K974909 | Synermed Creatinine Reagent KitCGX · Traditional | Synermed Intl., Inc. | 02/24/1998SE |
| K972743 | Sigma Diagnostics Creatinine Reagent, Sigma Diagnostics Creatinine ReagentCGX · Traditional | Sigma Diagnostics, Inc. | 09/22/1997SE |
| K971908 | Crea or CreatinineCGX · Traditional | Carolina Liquid Chemistries Corp. | 06/17/1997SE |
| K970087 | CR PerfectCGX · Traditional | Chimera Research & Chemical, Inc. | 03/06/1997SE |
| K963534 | Sigma Diagnostics Creatinine Reagent KitCGX · Traditional | Sigma Diagnostics, Inc. | 09/30/1996SE |
| K955938 | Creatinine ReagentCGX · Traditional | Derma Media Lab., Inc. | 03/12/1996SE |
| K954266 | STC Diagnostics Auto-Lyte Creatinine AssayCGX · Traditional | Solarcare Technologies Corp,Inc. | 10/13/1995SE |
| K951595 | Roche Cobas Integra Analyzer, Reagent CassettesCGX · Traditional | Roche Diagnostic Systems, Inc. | 09/08/1995SE |
| K950142 | CR PerfectCGX · Traditional | Chimera Research & Chemical, Inc. | 05/25/1995SE |
| K945655 | Creatinine (Enzymatic UV) Procedure for Technicon Systems (in Vitro Diagnostic Test…CGX · Traditional | Miles, Inc. | 01/05/1995SE |
| K943005 | Creatinine QvetCGX · Traditional | Prisma Systems | 11/22/1994SE |
| K943924 | Creatinine-Po Reagent KitCGX · Traditional | Synermed, Inc. | 09/20/1994SE |
| K941837 | Roche Reagent for CreatinineCGX · Traditional | Roche Diagnostic Systems, Inc. | 08/26/1994SE |
| K934071 | Kodak Ektachem DT Slides (Urcr)CGX · Traditional | Eastman Kodak Company | 03/21/1994SE |
| K934587 | Creatinine-S AssayCGX · Traditional | Diagnostic Chemicals , Ltd. | 03/11/1994SE |
| K934361 | Olympus Creatinine ReagentCGX · Traditional | Olympus Corp. | 11/16/1993SE |
| K933697 | Sigma Cre ReagentCGX · Traditional | Sigma Chemical Co. | 10/18/1993SE |
| K931939 | Olympus Creatinine ReagentCGX · Traditional | Olympus Corp. | 09/21/1993SE |
| K932160 | Systemate Creatinine Test Item Number 65413CGX · Traditional | Em Diagnostic Systems, Inc. | 07/09/1993SE |
| K926511 | Synermed Single Reagent Creatinine KitCGX · Traditional | Synermed, Inc. | 02/18/1993SE |
| K925668 | Creatinine Meth for Use on the Dimension Clin ChemCGX · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 12/28/1992SE |
| K924692 | Olympus Creatinine ReagentCGX · Traditional | Olympus Corp. | 10/19/1992SE |
| K924599 | Creatinine-Ip Test, # 42375/93, 42323/R1, 42323/R2CGX · Traditional | Em Diagnostic Systems, Inc. | 10/15/1992SE |
| K923526 | Olympus Creatinine ReagentCGX · Traditional | Olympus Corp. | 09/18/1992SE |
| K923203 | Systemate Creatinine TestCGX · Traditional | Em Diagnostic Systems, Inc. | 09/09/1992SE |
| K923039 | Miles Urine Creatinine MethodCGX · Traditional | Heraeus Kulzer, Inc. | 08/24/1992SE |
| K915077 | Synchron Creatinine Triggered Test CX4,5,7,CGX · Traditional | Beckman Instruments, Inc. | 12/18/1991SE |
| K913707 | Abbott Quickstart Creatinine Test(Crea) Item# 5A28CGX · Traditional | Em Diagnostic Systems, Inc. | 09/18/1991SE |
| K905658 | Systemate Creatinine (Epos Application) #65413CGX · Traditional | Em Diagnostic Systems, Inc. | 05/08/1991SE |
| K910147 | Creatinine Reagent(Creat), Cat.# RE0015/MODIFIEDCGX · Traditional | Olympus Corp. | 03/11/1991SE |
| K905619 | Creatinine (Rate) Reagent SetCGX · Traditional | Biochemical Trade, Inc. | 02/13/1991SE |
| K893582 | N-A-G Test KitCGX · Traditional | Ppr Diagnostics , Ltd. | 10/01/1990SE |
| K902561 | Roche Cobas Ready Creatinine ReagentCGX · Traditional | Roche Diagnostic Systems, Inc. | 09/07/1990SE |
| K903296 | Synermed Creatinine Reagent KitCGX · Traditional | Synermed, Inc. | 08/17/1990SE |
| K902172 | Coulter Creatinine ReagentCGX · Traditional | Coulter Corp. | 06/28/1990SE |
| K901229 | Chem 1 Clinical Analyzer (Method Urine Creatinine)CGX · Traditional | Technicon Instruments Corp. | 05/04/1990SE |
| K901298 | Creatinine Reagent for AU5000 Clin Lab Anal-ModifyCGX · Traditional | Olympus Corp. | 04/25/1990SE |
| K900666 | Amresco Creatinine Reagents Product #7790, 7791CGX · Traditional | American Research Products Co. | 04/19/1990SE |
| K896686 | Amresco Creatinine Reagent #4316100CGX · Traditional | American Research Products Co. | 02/08/1990SE |
| K895847 | Creatinine 340 (Enzymatic)CGX · Traditional | Sclavo, Inc. | 10/30/1989SE |
| K895022 | Systemate Creatinine Test (Crea) #65413CGX · Traditional | Em Diagnostic Systems, Inc. | 10/23/1989SE |
| K890671 | Hi Chem Creatinine Reagent (Product #88809)CGX · Traditional | Hichem Diagnostics | 05/09/1989SE |
| K884734 | Creatinine Test (Crea) Item #65663CGX · Traditional | Em Diagnostic Systems, Inc. | 12/19/1988SE |
| K881856 | Biotrol Creatinine H.P. ReagentCGX · Traditional | Biotrol, USA, Inc. | 06/16/1988SE |
| K881400 | Creatinine for Continuous Flow InstrumentsCGX · Traditional | Catachem, Inc. | 04/28/1988SE |
| K880843 | Creatinine Reagent Set (Kinetic)CGX · Traditional | Tech-Neal Scientific, Inc. | 04/05/1988SE |
| K880629 | CreatinineCGX · Traditional | Tech-Co, Inc. | 03/23/1988SE |
| K873531 | Paramax Creatinine ReagentCGX · Traditional | Baxter Healthcare Corp | 11/23/1987SE |
| K874088 | Easy-Test Creatinine (Crea) Item No. 19009CGX · Traditional | Em Diagnostic Systems, Inc. | 11/06/1987SE |
| K873131 | Creatinine Reagent KitCGX · Traditional | A-Kem, Inc. | 10/23/1987SE |
| K873725 | Multichem Creatinine Reagent S0917CGX · Traditional | Simmler, Inc. | 10/20/1987SE |
| K873365 | Creatinine ReagentCGX · Traditional | Sigma Diagnostics, Inc. | 10/02/1987SE |
| K873310 | Abbott Spectrum(R) Liquid Creatinine ReagentCGX · Traditional | Abbott Laboratories | 09/02/1987SE |
| K872310 | Curad Medicated Plastic StripsCGX · Traditional | The Kendal Co. | 08/28/1987SE |
| K870366 | Creatinine Reagent - Picric Acid MethodCGX · Traditional | Trace Scientific , Ltd. | 08/19/1987SE |
| K863079 | CreatinkineticCGX · Traditional | J. D. Assoc. | 12/12/1986SE |
| K863738 | Emds(Tm) Creatinine(Crea) Testpacks, #67669/95CGX · Traditional | Em Diagnostic Systems, Inc. | 11/05/1986SE |
| K863261 | Creatinine ProcedureCGX · Traditional | Data Medical Associates, Inc. | 10/02/1986SE |
| K861655 | Creatinine ProcedureCGX · Traditional | Data Medical Associates, Inc. | 07/01/1986SE |
| K861819 | Kodak Ektachem Clinical Chemistry Slides (Crea)CGX · Traditional | Eastman Kodak Company | 06/11/1986SE |
| K860418 | Creatinine Reagent SetCGX · Traditional | Sterling Diagnostics, Inc. | 02/11/1986SE |
| K855193 | Creatinine Reagent SetCGX · Traditional | Technostics Intl. | 01/14/1986SE |
| K854846 | Vision CreatinineCGX · Traditional | Abbott Laboratories | 01/13/1986SE |
| K854178 | In-Vitro Test for the Determination of CreatinineCGX · Traditional | Clinical Data, Inc. | 11/25/1985SE |
| K853888 | Amresco Flow Pac Creatinine Color Reagent 2310 &CGX · Traditional | American Research Products Co. | 10/15/1985SE |
| K852565 | Technicon ChemiCGX · Traditional | Technicon Instruments Corp. | 07/12/1985SE |
| K850932 | CreatinineCGX · Traditional | Dilab, Inc. | 06/25/1985SE |
| K851993 | Cre Buffer Cre DyeCGX · Traditional | Alpkem Corp. | 05/30/1985SE |
| K851849 | Creatine Liquid Stable Reagent SetCGX · Traditional | Medical Analysis Systems, Inc. | 05/20/1985SE |
| K844332 | Creatinine Reagent for Demand AnalyzerCGX · Traditional | Advanced Biomedical Methods, Inc. | 01/03/1985SE |
| K844024 | Creatinine Reagent SetCGX · Traditional | Livonia Diagnostics, Inc. | 10/30/1984SE |
| K843916 | TDX Rea CreatinineCGX · Traditional | Abbott Laboratories | 10/30/1984SE |
| K843377 | Creatinine Assay KitCGX · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 09/28/1984SE |
| K843179 | Creatinine TestCGX · Traditional | Sclavo, Inc. | 09/07/1984SE |
| K843105 | Systemate Creatinine 67223CGX · Traditional | Em Diagnostic Systems, Inc. | 08/27/1984SE |
| K842159 | Creatinine Assay Kit-Kinetic or EndpointCGX · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 08/16/1984SE |
| K841377 | Creatinine - A.A.S.CGX · Traditional | Advanced Analytical Systems, Inc. | 05/11/1984SE |
| K840872 | Raichem Creatinine ReagentCGX · Traditional | Reagents Applications, Inc. | 04/18/1984SE |
| K832439 | Creatinine Reagent SetCGX · Traditional | Amresco, Inc. | 01/17/1984SE |
| K831628 | Creatinine Reagents B6370-13CGX · Traditional | American Scientific Products | 07/06/1983SE |
| K831627 | Creatinine Reagents B6360-10CGX · Traditional | American Scientific Products | 07/06/1983SE |
| K830556 | CreatinineCGX · Traditional | Pointe Scientific, Inc., | 03/24/1983SE |
| K830537 | Flow-Pac Creatinine Reagent SetCGX · Traditional | Amresco, Inc. | 03/24/1983SE |
| K830447 | Kinetic CreatinineCGX · Traditional | American Monitor Corp. | 03/24/1983SE |
| K823806 | Direct Creatinine ProcedureCGX · Traditional | Analytical & Research Chemicals, Inc. | 01/14/1983SE |
| K823573 | Cobas Reagent for CreatinineCGX · Traditional | Hoffmann-La Roche, Inc. | 01/07/1983SE |
| K823572 | Cobas Standards for CreatinineCGX · Traditional | Hoffmann-La Roche, Inc. | 01/07/1983SE |
| K822118 | Fermcotest Creatinine Test ReagentCGX · Traditional | Fermco Biochemics, Inc. | 09/30/1982SE |
| K821881 | Ultrachem CreaCGX · Traditional | Harleco Diagnostics | 07/14/1982SE |
| K821199 | Creatinine Reagent SetCGX · Traditional | Omega Medical Electronics | 07/13/1982SE |
| K813560 | Liquizyme Creatinine Reagent SetCGX · Traditional | Amresco, Inc. | 01/29/1982SE |
| K820075 | Seralyzer Creatinine Reagent StripsCGX · Traditional | Miles Laboratories, Inc. | 01/26/1982SE |
| K812834 | Creatinine Reagent SetCGX · Traditional | Anco Medical Reagents & Assoc. | 12/03/1981SE |
| K813043 | Ultrachem Crea Item #64972CGX · Traditional | Harleco | 11/10/1981SE |
| K812109 | Gilchem Creatinine ReagentCGX · Traditional | Gilford Diagnostics | 08/13/1981SE |
| K811406 | Creatinine Rate Reagent KitCGX · Traditional | Chem-Elec, Inc. | 08/13/1981SE |
| K811659 | Creatinine ReagentCGX · Traditional | Gilford Diagnostics | 06/26/1981SE |
| K811664 | Creatinine TestCGX · Traditional | King Diagnostics, Inc. | 06/25/1981SE |
| K803087 | Lancer Creatinine Microsample Stat AnaCGX · Traditional | Sherwood Medical Co. | 01/02/1981SE |
| K802156 | Reagents Serum Creatine Using TechiconCGX · Traditional | Panmed, Inc. | 10/10/1980SE |
| K800685 | Reagent for Determ. Creatinine in H/SeruCGX · Traditional | Diagnostic Solutions, Inc. | 05/28/1980SE |
| K800583 | Nsi Creatinine KitCGX · Traditional | Nobel Scientific Industries, Inc. | 04/02/1980SE |
| K800219 | Serum Creatinine; Alk. Buffer & PicricCGX · Traditional | Fisher Scientific Co., LLC | 02/26/1980SE |
| K792404 | Elvi CreatinineCGX · Traditional | Volu Sol Medical Industries | 12/07/1979SE |
| K792402 | Elvi CreatininCGX · Traditional | Volu Sol Medical Industries | 12/07/1979SE |
| K792397 | Elvi CreatinineCGX · Traditional | Volu Sol Medical Industries | 12/07/1979SE |
| K791994 | Creatinine Diag. Reagent Picric AcidCGX · Traditional | Connecticut Diagnostics, Ltd. | 10/17/1979SE |
| K791689 | Picric SolutionCGX · Traditional | Hi Chem, Inc. | 09/17/1979SE |
| K791688 | Alkaline BufferCGX · Traditional | Hi Chem, Inc. | 09/17/1979SE |
| K790044 | Reagent Kit, Bakers DiagnosticCGX · Traditional | J.T. Baker Chemical Co. | 02/22/1979SE |
| K782094 | HilarCGX · Traditional | Hi Chem, Inc. | 01/17/1979SE |
| K781884 | Serum, Creatinine DeterminationsCGX · Traditional | Fisher Scientific Co., LLC | 12/20/1978SE |
| K781396 | Creatinine Reagent SetCGX · Traditional | Nobel Scientific Industries, Inc. | 09/14/1978SE |
| K780514 | Ultrachem Creatinine 64972, CentrifuchemCGX · Traditional | Harleco | 05/19/1978SE |
| K772157 | Creatinine, 64972CGX · Traditional | Harleco | 12/06/1977SE |
| K772107 | Creatinine Urine APPLI.-#32308CGX · Traditional | Harleco | 11/28/1977SE |
| K771856 | Dir. Quant. Color. Determ. Serum Creat.CGX · Traditional | Stanbio Laboratory | 11/03/1977SE |
| K771834 | CreatinineCGX · Traditional | Gamma Enterprises, Inc. | 11/03/1977SE |
| K771916 | Procedure No. 555CGX · Traditional | Sigma Chemical Co. | 10/19/1977SE |
| K771773 | Clinicard Creatinine ChemistryCGX · Traditional | Harleco | 10/14/1977SE |
| K771443 | Multistat III Creatinine TestCGX · Traditional | Instrumentation Laboratory CO | 08/22/1977SE |
| K771365 | Creatinine Analysis ProductsCGX · Traditional | Abbott Laboratories | 08/16/1977SE |
| K771335 | Creatinine Analyzer 2CGX · Traditional | Beckman Instruments, Inc. | 08/03/1977SE |
| K770819 | Ultrachem CreatinineCGX · Traditional | Harleco | 07/11/1977SE |
| K770643 | Creatinine Test, Super SeventeenCGX · Traditional | Hycel, Inc. | 06/24/1977SE |
| K770454 | Creatinine Procedure, TekpointCGX · Traditional | Icn Pharmaceuticals, Inc. | 05/03/1977SE |
| K770242 | Reagent SystemCGX · Traditional | American Monitor Corp. | 02/22/1977SE |
| K761280 | Auto Creatinine Reagent (Gilford 3400-E)CGX · Traditional | Harleco | 02/14/1977SE |
| K761279 | Auto Creatinine Reagent (Abbott System)CGX · Traditional | Harleco | 02/11/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1980-2026 Class II | Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge… | Siemens Healthcare Diagnostics, Inc. | 03/18/2026Open, Classified |
| Z-1586-2022 Class II | a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-2431-2020 Class II | Atellica CH Chemistry CalibratorCalibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry… | Siemens Healthcare Diagnostics, Inc. | 06/05/2020Terminated |
| Z-0931-2017 Class III | Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | Sterling Diagnostics, Inc. | 07/20/2016Terminated |
| Z-0739-2016 Class II | ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the…N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with… | Horiba Instruments Inc | 01/11/2016Terminated |
| Z-2773-2015 Class III | Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic…Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and… | Pointe Scientific, Inc. | 12/12/2014Terminated |
| Z-0958-2013 Class II | Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the…Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) IFU and… | Beckman Coulter Inc. | 12/28/2012Terminated |
| Z-0289-2013 Class III | ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers:…This recall was initiated because some customers were experiencing an alarm during Creatinine calibration… | Horiba Instruments, Inc dba Horiba Medical | 09/14/2012Terminated |
| Z-0772-2012 | Dimension(R) Creatinine Flex(R) Reagent Cartridges. The CREA method is an in vitro…Siemens has confirmed the potential for falsely elevated creatinine results with CREA FLex(R) reagent… | Siemens Healthcare Diagnostics, Inc. | 11/22/2011Terminated |
| Z-1729-2011 | Dimension(R) Creatinine Flex(R) Reagent Cartridges The CREA method is an in vitro…Firm has confirmed the potential for falsely elevated creatinine results with specified CREA Flex(R) reagent… | Siemens Healthcare Diagnostics, Inc. | 12/27/2010Terminated |
| Z-2389-2010 | SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525 Systems AQUA…The recall was initiated after Beckman Coulter confirmed reports that black / brown particulates were… | Beckman Coulter Inc. | 08/02/2010Terminated |
| Z-1036-2010 | Pointe Scientific Creatinine Reagent R2, Pointe Scientific, Inc., Canton, MI; Catalog…An additional 10% picric acid was added to the R2 component during production. | Pointe Scientific, Inc. | 12/01/2009Terminated |
| Z-1035-2010 | Pointe Scientific Creatinine Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog #…An additional 10% picric acid was added to the R2 component during production. | Pointe Scientific, Inc. | 12/01/2009Terminated |
| Z-0012-2009 | Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics…Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. | Roche Diagnostics Corp. | 06/11/2008Terminated |